The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for TicoVac™ (Pfizer), an investigational vaccine for active immunization to prevent tick-borne encephalitis in individuals 1 year of age and older.
TicoVac is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the tick-borne encephalitis virus found in nature. Tick-borne encephalitis is a viral infection of the brain and spine that is transmitted through the bite of an infected tick.
The BLA is based on data from clinical trials that assessed the safety and immunogenicity of the vaccine across 2 age groups (1-15 years of age and 16-65 years of age). Results from these trials showed that after 3 doses of the vaccine, the pooled seropositivity rates were 99-100% in individuals 1-15 years old and 94-99% in those 16 years of age and older. As for safety, the vaccine was found to be well tolerated with no unexpected adverse events or vaccine-related serious adverse events observed.
Additionally, subsequent real-world studies showed that the vaccine was 96-99% effective in individuals treated with at least 2 doses, and provided long-lasting immune memory following 2 to 3 doses.
“We are proud that today’s US FDA Priority Review acceptance acknowledges the potential value that our vaccine candidate can bring,” said Nanette Cocero, PhD, Global President, Vaccines, Pfizer Inc. “If approved in the US, we hope this vaccine will help protect those traveling to or residing temporarily in at-risk locations, potentially including military personnel who are serving overseas.”
A Prescription Drug User Fee Act (PDUFA) target date of August 2021 is expected for the application.
US FDA accepts for Priority Review Pfizer’s application for TicoVac™ (tick-borne encephalitis vaccine). [press release]. New York, NY: Pfizer, Inc.; February 23, 2021.